| CTRI Number |
CTRI/2019/03/018041 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
08/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of two drugs methylprednisolone and etoricoxib in laproscopic surgery |
|
Scientific Title of Study
|
Evaluation of the efficacy of a combination of Methylprednisolone and Etoricoxib to attenuate postoperative pain and PONV in patients undergoing laparoscopic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek sharma |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460644288 |
| Fax |
|
| Email |
drvikkysh71289@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar lal nehru medical college ajmer |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Jln Medical College ajmer |
| Address |
Department of anaesthesia jln medical college ajmer |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek sharma |
Jln Medical College ajmer |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN |
9460644288
drvikkysh71289@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Compare between NS intravenously (IV) plus a placebo tablet and methylprednisolone 125 mg IV plus a 120 mg tablet of etoricoxib |
1.To assess fentanyl dose consumption.
2.To assess duration of analgesia.
3.To assess and compare the quality of Post op analgesia
4. To assess and compare the hemodynamic changes if any.
5. To assess and compare the proportion of patient having adverse
effects and any other complications.
6. To evaluate its effects on PONV, fatigue, sedation. |
| Intervention |
Evaluate the Efficacy of a Combination of Methylprednisolone(125mg IV) And Etoricoxib(120mgORALLY) |
1. To evaluate the effect on Post operative Pain.
2 .To evaluate the effect on PONV. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients (20-65 yrs) of either sex
2.ASA physical status I or II
3.Patients scheduled for laparoscopic Surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.ASA Physical Status III or above
2.Patients with impaired kidney or liver functions,
3.A history of drug or alcohol abuse
4.A history of chronic pain or daily intake of analgesics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect on Post operative Pain.
2 .To evaluate the effect on PONV. |
1. To evaluate the effect on Post operative Pain.
2 .To evaluate the effect on PONV. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess fentanyl dose consumption.
2.To assess duration of analgesia.
3.To assess and compare the quality of Post op analgesia
4. To assess and compare the hemodynamic changes if any.
5. To assess and compare the proportion of patient having adverse
effects and any other complications.
6. To evaluate its effects on PONV, fatigue, sedation. |
Duration of study is around one year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to Evaluate the Efficacy of a Combination of Methylprednisolone(125mg IV) And Etoricoxib(120mgORALLY) to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Surgery in the terms of:-
PRIMARY OBJECTIVES: 1. To evaluate the effect on Post operative Pain. 2 .To evaluate the effect on PONV.
SECONDARY OBJECTIVES: 1.To assess fentanyl dose consumption. 2.To assess duration of analgesia. 3.To assess and compare the quality of Post op analgesia 4. To assess and compare the hemodynamic changes if any. 5. To assess and compare the proportion of patient having adverse effects and any other complications. 6. To evaluate its effects on PONV, fatigue, sedation. |